ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announced that the Scottish Medicines Consortium (SMC) has issued a positive recommendation for the use of Jetrea (ocriplasmin) for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Today’s positive recommendation represents a reversal of the original SMC decision made in August 2013 and results from the submission of further data highlighting the economic value of Jetrea when used to treat adults with VMT, a progressive sight-threatening condition that can lead to the loss of central vision, distorted vision, and blindness.
Until recently, the clinical approach has been ‘watch and wait’ or monitoring of VMT patients, meaning patients must undergo a period of observation before they become eligible for vitrectomy surgery. Due to potential complications, vitrectomy is mostly performed at later stages of the disease, often with macular hole, when patients have advanced symptoms and any lost vision may not be fully recovered. Therefore, monitoring of VMT patients can be risky, as it may lead to disease progression, and in some cases, irreversible vision loss or damage to the retina.
Dr Patrik De Haes, CEO of ThromboGenics, says: “The SMC’s decision to now recommend the use and reimbursement of Jetrea follows earlier positive assessments and reimbursement decisions in a range of countries, both in Europe and globally. We are pleased that our market access activities are providing such a strong platform for the roll out of Jetrea across Europe, and we trust that this reimbursement support will in time allow the broad use of this novel medicine for the treatment of patients with VMT.”
Jetrea is the first pharmacological treatment for this indication and was approved by the European Commission in the European Union in March 2013.
ThromboGenics’ partner Alcon holds the commercialization rights to Jetrea outside the US and is responsible for the marketing of Jetrea in Scotland.
Jetrea (ocriplasmin) is a truncated form of human plasmin. In the US, Jetrea is indicated for the treatment of symptomatic VMA. In Europe, Jetrea is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
Jetrea has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
Jetrea’s phase III programme found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The phase III programme also showed that Jetrea was generally well tolerated with most adverse events being transient and mild in severity.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of Jetrea outside the United States.